Core Viewpoint - Hagens Berman is conducting an investigation into uniQure N.V. following significant criticisms from the FDA regarding the company's gene therapy candidate AMT-130, which has been labeled a "failed therapy" due to alleged data manipulation and misrepresentation of clinical study designs [1][2]. Group 1: FDA Allegations - An FDA official accused uniQure of performing a "distorted or manipulated comparison" in its clinical studies, rather than conducting proper research [2]. - The FDA has not approved the use of the ENROLL-HD external historical data set as a primary control for AMT-130, indicating a lack of regulatory consensus on the study's design [5]. - The FDA official clarified that the agency's request regarding sham surgeries was mischaracterized by uniQure, stating that the requirement was for "one to three nicks in the scalp" rather than more invasive procedures [4]. Group 2: Class Action Lawsuit - A securities class action lawsuit has been filed against uniQure, alleging that the company misrepresented its interactions with the FDA and failed to disclose critical information regarding its clinical study designs during the Class Period from September 24, 2025, to October 31, 2025 [3][4]. - The lawsuit claims that uniQure misled investors about the necessity of a sham-controlled surgery arm for Phase III trials, which the FDA asserts was never waived [5]. - The stock price of uniQure dropped by 49% following the revelation of the lack of FDA agreement on the Biologics License Application (BLA) timeline, which was previously presented as clear by the company [5]. Group 3: Investor Information - Investors who purchased uniQure shares during the Class Period and suffered losses have until April 13, 2026, to apply for Lead Plaintiff status in the ongoing class action [6].

Core Viewpoint - A class action lawsuit has been initiated against uniQure N.V. for allegedly issuing misleading statements regarding its Pivotal Study and Biologics License Application (BLA) timeline, potentially impacting shareholders who purchased shares during the specified class period [2][3]. Summary by Sections Allegations - The lawsuit claims that uniQure's management made materially false and misleading statements, including: 1. The design of the Pivotal Study was not fully approved by the FDA [2]. 2. The likelihood of delaying the BLA timeline due to the need for additional studies was downplayed [2]. 3. Consequently, the statements regarding the company's business and prospects lacked a reasonable basis [2]. Class Period and Deadlines - The class period for the lawsuit is defined as September 24, 2025, to October 31, 2025 [2]. - Shareholders are encouraged to register for the class action by April 13, 2026, to be eligible for potential recovery [3]. Next Steps for Shareholders - Registered shareholders will be enrolled in a portfolio monitoring system to receive updates on the case [3]. - Participation in the case incurs no cost or obligation for shareholders [3]. Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm focused on protecting investors' rights against deceit and fraud [4].

Core Viewpoint - A class action lawsuit has been filed against uniQure N.V. for allegedly misleading investors regarding the progress of its pivotal study for Huntington's disease, leading to significant stock price fluctuations [1][3]. Company Overview - uniQure N.V. is a biotechnology company based in Amsterdam, specializing in gene therapies for rare and severe diseases, with its lead product candidate being AMT-130, currently in clinical trials for Huntington's disease [2]. Legal Proceedings - The lawsuit claims that uniQure misled investors about the design and progress of the pivotal study, which led to a nearly 250% spike in share prices following the announcement of positive topline results on September 24, 2025 [3]. - On November 3, 2025, uniQure disclosed that the FDA did not accept the Phase I/II study data as sufficient for a Biologics License Application (BLA) submission, resulting in a nearly 50% drop in share prices from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [4].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased ordinary shares of uniQure N.V. between September 24, 2025, and October 31, 2025, about the April 13, 2026, deadline to become a lead plaintiff in a class action lawsuit [1] Group 1: Class Action Details - Investors who bought uniQure shares during the specified period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1] - A class action lawsuit has already been filed, and interested parties must move the Court by April 13, 2026, to serve as lead plaintiff [2] - The lawsuit claims that uniQure misrepresented and/or failed to disclose critical information regarding its Pivotal Study and the likelihood of delays in its Biologics License Application (BLA) timeline [4] Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements, including the largest securities class action settlement against a Chinese company [3] - The firm has been ranked No. 1 for securities class action settlements in 2017 and has consistently ranked in the top 4 since 2013, recovering hundreds of millions of dollars for investors [3] - In 2019, the firm secured over $438 million for investors, showcasing its effectiveness in litigation [3]

Core Viewpoint - Hagens Berman is conducting an investigation into uniQure N.V. following significant criticisms from the FDA regarding the company's gene therapy candidate AMT-130, which has been labeled a "failed therapy" and accused of using distorted data in clinical comparisons [1][2]. Group 1: FDA Allegations - An FDA official criticized uniQure for allegedly performing a "distorted or manipulated comparison" in its clinical studies instead of adhering to proper protocols [2]. - The FDA has not approved the use of the ENROLL-HD external historical data set as a primary control for AMT-130, indicating a lack of regulatory consensus on the therapy's evaluation [5]. Group 2: Class Action Lawsuit Details - The securities class action lawsuit, Scocco v. uniQure N.V., alleges that uniQure misrepresented its interactions with the FDA and failed to disclose critical information regarding its clinical study design [3][4]. - Specific allegations include mischaracterization of sham surgeries, denial of prior agreements with the FDA, and misleading statements about the eligibility of AMT-130 for streamlined pathways [4][5]. Group 3: Impact on Investors - The stock price of uniQure fell by 49% following the revelation of the lack of FDA agreement on the Biologics License Application (BLA) timeline, which was previously presented as clear [5]. - Investors who purchased shares during the class period (September 24, 2025 – October 31, 2025) are reminded of the April 13, 2026, deadline to apply as Lead Plaintiff in the ongoing lawsuit [6].

Core Viewpoint - A securities fraud class action lawsuit has been filed against uniQure N.V. for misleading investors regarding its gene therapy drug AMT-130 during the specified Class Period [2][4][5]. Group 1: Lawsuit Details - The lawsuit was filed by Kessler Topaz Meltzer & Check, LLP on behalf of investors who purchased uniQure ordinary shares between September 24, 2025, and October 31, 2025 [2][7]. - The deadline for investors to seek lead plaintiff status is April 13, 2026 [3][9]. - The case is titled Scocco v. uniQure N.V., et al., and is being heard in the United States District Court for the Southern District of New York [2]. Group 2: Allegations Against uniQure - The complaint alleges that uniQure made materially false and misleading statements regarding its Phase I/II clinical trials and the timeline for its Biologics License Application (BLA) submission to the FDA [4][5]. - Specific allegations include that the design of the Pivotal Study was not fully approved by the FDA and that uniQure downplayed the likelihood of needing to delay its BLA timeline due to additional studies [5][6]. - On November 3, 2025, uniQure disclosed that the FDA no longer agreed that the data from the Phase I/II studies would be adequate for BLA submission, leading to a significant drop in share price [6][8]. Group 3: Impact on Share Price - Following the disclosure on November 3, 2025, uniQure's share price fell by $33.40, or over 49%, from $67.69 to $34.29 per share [8].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against UniQure N.V. due to alleged violations of federal securities laws, encouraging affected investors to contact them for legal options [2][4]. Group 1: Allegations Against UniQure - The complaint alleges that UniQure and its executives made false and misleading statements regarding the FDA approval of their Pivotal Study, which was not fully approved [4]. - It is claimed that the company downplayed the likelihood of needing to delay its Biologics License Application (BLA) timeline to conduct additional studies, despite previously reported successful results [4]. - As a result of these actions, the statements made by the defendants about the company's business and prospects lacked a reasonable basis [4]. Group 2: Impact of FDA Disclosure - On November 3, 2025, UniQure disclosed that the FDA no longer agreed that data from the Phase I/II AMT-130 studies would support a BLA submission, leading to uncertainty about the timing of any submission [5]. - Following this disclosure, UniQure's share price fell by $33.40, or over 49%, dropping from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [6]. Group 3: Legal Proceedings - Investors who purchased UniQure securities between September 24, 2025, and October 31, 2025, are reminded of the April 13, 2026, deadline to seek the role of lead plaintiff in the federal securities class action against the company [2]. - The lead plaintiff is defined as the investor with the largest financial interest in the relief sought, who will oversee the litigation on behalf of the class [7]. Group 4: Call for Information - Faruqi & Faruqi encourages anyone with information regarding UniQure's conduct, including whistleblowers and former employees, to contact the firm [8].

Core Viewpoint - The Gross Law Firm is notifying shareholders of uniQure N.V. regarding a class action lawsuit due to alleged misleading statements and omissions related to the company's Pivotal Study and Biologics License Application timeline [1][3]. Group 1: Allegations - The complaint alleges that during the class period from September 24, 2025, to October 31, 2025, uniQure's management issued materially false and/or misleading statements [3]. - It is claimed that the design of uniQure's Pivotal Study was not fully approved by the FDA, which was not disclosed to investors [3]. - The likelihood of a delay in the Biologics License Application timeline due to the need for additional studies was downplayed, leading to a lack of reasonable basis in the company's statements about its business and prospects [3]. Group 2: Class Action Details - Shareholders are encouraged to register for the class action lawsuit by April 13, 2026, to potentially be appointed as lead plaintiffs [4]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the case's progress [4]. - There is no cost or obligation for shareholders to participate in the case [4]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [5].

Core Viewpoint - The investigation into uniQure N.V. is prompted by significant criticisms from FDA officials regarding the company's gene therapy candidate AMT-130, leading to a securities class action lawsuit for investors who acquired shares during a specified period [1][3][5]. Group 1: FDA Criticism - An FDA official labeled AMT-130 as a "failed therapy" and accused uniQure of conducting a "distorted or manipulated comparison" in its clinical studies [3]. - The FDA has not approved the use of the ENROLL-HD external historical data set as a primary control for AMT-130, indicating a lack of regulatory consensus [8]. - The FDA official clarified that the agency's requirements for sham surgeries were mischaracterized by uniQure, stating that the FDA did not request invasive procedures [7]. Group 2: Class Action Allegations - The securities class action alleges that uniQure misrepresented its interactions with the FDA and failed to disclose critical information regarding its pivotal study design [5][6]. - Allegations include misleading investors about the necessity of a sham-controlled surgery arm for Phase III trials, which the FDA claims was never waived [8]. - The lawsuit also points to a timeline deception regarding the Biologics License Application (BLA), which became unclear after the FDA's lack of agreement was revealed, resulting in a 49% drop in stock value [8]. Group 3: Investor Information - Investors who purchased uniQure shares between September 24, 2025, and October 31, 2025, are encouraged to participate in the class action, with a deadline for Lead Plaintiff applications set for April 13, 2026 [1][6].

Core Viewpoint - A class action lawsuit has been filed against uniQure N.V. for allegedly misleading investors regarding the likelihood of FDA approval for its leading drug candidate, AMT-130, during the period from September 24, 2025, to October 31, 2025 [2][3]. Group 1: Allegations and Impact - Robbins LLP is investigating allegations that uniQure misled investors about the FDA approval likelihood of AMT-130, claiming that the design of the pivotal study was not fully approved by the FDA and that the company downplayed the need for additional studies [2]. - On November 3, 2025, uniQure announced that the FDA no longer agreed that the data from the Phase I/II studies were adequate for a Biologics License Application (BLA) submission, leading to a significant stock price drop of $33.40 per share, or over 49%, from $67.69 to $34.29 [3]. Group 2: Shareholder Actions - Shareholders may be eligible to participate in the class action and must submit their papers to the court by April 13, 2026, if they wish to serve as lead plaintiffs [4]. - Participation in the case is not required to be eligible for recovery, allowing shareholders to remain absent class members if they choose [4]. Group 3: Legal Representation - Robbins LLP operates on a contingency fee basis, meaning shareholders incur no fees or expenses unless the case is won [5]. - The firm has a history of advocating for shareholder rights and aims to help recover losses and improve corporate governance [5].